Global Quality & Regulatory Affairs Leader

Unimed Maritime Solutions; Miami (FL); On-site; USD 180,000 - 280,000; Full time

Job summary

Unimed Maritime Solutions seeks a senior leader to drive global compliance, regulatory and quality programs across the organization. You will be the Senior Management Team member, accountable for GDP, GMP, ISO compliance and data governance, including AI-enabled systems.

You will lead the Quality and Regulatory Affairs team, oversee inspections, audits, CAPAs and supplier qualification, and partner with executives to embed practical controls in day-to-day operations.

Qualifications

• Bachelor's degree in Pharmacy, Health Sciences or a related field.
• Minimum 8 years of senior-level compliance, regulatory and quality experience in regulated industries.
• Deep knowledge of GDP, GMP, ISO standards and QMS.
• Experience with CAPAs, deviations, recalls, inspections, audits and document control.
• Fluent English, strong leadership and communication skills.

Responsibilities

• Lead global regulatory compliance, registrations and licenses with authorities.
• Own and improve the global Quality Management System and governance.
• Build and oversee the Quality and Regulatory Affairs team across sites.
• Manage CAPAs, deviations, change controls, investigations and remediation.
• Oversee sanctions screening and due diligence across jurisdictions.
• Lead inspections, audits and corrective actions; report KPIs to executives.

Skills

Regulatory compliance

Quality management

GMP GDP ISO knowledge

Leadership

Data governance

Education

Bachelor's degree in Pharmacy

Quality or regulatory qualification (advantage)

Tools

GAMP 5

ISO 9001

Job description

Unimed Maritime Solutions seeks a senior leader to drive global compliance, regulatory and quality programs across the organization. You will be the Senior Management Team member, accountable for GDP, GMP, ISO compliance and data governance, including AI-enabled systems.

You will lead the Quality and Regulatory Affairs team, oversee inspections, audits, CAPAs and supplier qualification, and partner with executives to embed practical controls in day-to-day operations.